MAUDE Adverse Event Report: RICHARD WOLF GMBH; TEM TUBE SET

Model Number 4170801

Device Problems Misconnection (1399); Misassembled During Installation (4049)

Patient Problem Insufficient Information (4580)

Event Date 12/06/2022

Event Type  Injury  

Manufacturer Narrative

The reported device was received by richard wolf gmbh for investigation on 12/19/2022.(b)(4).The customer has received (b)(4) pieces from this batch.In the complaint database, there is no further complaints from the batch 32086110 between 01-01-2019 and 12-06-2022.According to the end user, they have more pieces from different batches, but they have not discovered the reported issue at those pieces.Rw gmbh has checked 9 pieces from remained samples of the batch.The reported issue could not be confirmed.The reported device was forwarded to the supplier for further investigation.The investigation is pending.

Event Description

Rwgmbh reference complaint no.(b)(4).The user reported the following: "there were several issues: 1.The tem irrigation cannula had a valve incorrectly assembled by the external reprocessing company, therefore the irrigation cannula did not work and a working replacement was taken from the 2nd [sieb].This problem was resolved with delay.2.When connecting the tem tubing set, the red connector of the suction tubing "d" could not be connected to the instrument, because this tubing is obviously reversed in the bundle of the tubing set (large red and small red connector each reversed on wrong side of the tubing set)." according to the user, there was delay of one hour and the planned procedure could not be completed.The user needed to switch to another surgical method with poorer imaging, as a result that the tumor could not be safely removed completely and from the healthy tissue.In follow-up care, deterioration of the prognosis or further surgery must be expected.Rwgmbh mdr awareness date: (b)(6) 2022.

Manufacturer Narrative

The reported device tem tube set 4170801 from the batch 32086110 was investigated by the supplier.The reported issue was confirmed.The tube with red connectors was assembled incorrectly into the bundle of tubes.The root cause is a production failure.The tem tube set 4170801 from the batch 32086110 was manufactured on 22/feb/2020.The batch consisted of 777 sets.No issue was identified during production, the retain samples at the side of the supplier and at richard wolf gmbh were reviewed, but the reported issue could not be confirmed at those samples.No further complaints were received regarding the reported issue.The ifu ga-as 001-usa / en / 2014-01 v7.0 / eco 2013-0434 contains safety notes of check the complete device system including the tem tube set before use in section 3.1 installation of the tem combination system and in section 5 checks.The user is advised to have a back-up device available in case of a device failure in section 1.2.2 tem pump.The subject issue of delay in the procedure is present in the risk management file p08fo015 e1-1: laparoscopic insufflators (incl.Tem) with accessories, rev.V00.The overall probability of occurrence for this issue remains at previously defined levels and overall risk of the device remains in the acceptable category.

• Brand Name: NA
• Type of Device: TEM TUBE SET
• Manufacturer (Section D): RICHARD WOLF GMBH; pforzheimer strasse 32; d-75438 knittlingen, germany ; GM
• Manufacturer (Section G): RICHARD WOLF GMBH; pforzheimer strasse 32; d-75438, knittlingen, germany ; GM
• Manufacturer Contact: zsófia bartholome-nagy ; pforzheimer strasse 32; d-75438, knittlingen, germany ; GM
• MDR Report Key: 16098615
• MDR Text Key: 306679871
• Report Number: 9611102-2023-00001
• Device Sequence Number: 1
• Product Code: HIF
• Combination Product (y/n): N
• Reporter Country Code: AU
• PMA/PMN Number: K000180
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Physician
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date: 03/02/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/04/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Model Number: 4170801
• Device Catalogue Number: 4170.801
• Device Lot Number: 32086110
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/19/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/15/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/22/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other